NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

9

1. Pages 15-17 were added to provide explanation of the different Statuses users can see on the Account

Details page as they relate to CVB-IC General Correspondence (2048) submissions.

PublicaƟon Date: 1/17/2020   Page 1

Where were changes made in the 1/17/2020 version?

1. Updates were made to eAuthentication account references

2. Page 4 - Updates to the Submission Type options

3. Page 5 - Updates to the Submission Subtype options

4. Page 13 - Updates to the CVB Response Types

Where were changes made in the 10/20/2016 version?
PublicaƟon Date: 1/17/2020   Page 2

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Any user with a verified identity 

eAuth account can enter the 2048 

informaƟon. Quality Review Users 

have Read Only Access to All 

submissions. 

Only Liaisons and Alternate Liaisons 

may submit to the CVB.

Next ‐ Entering information in the Inspection

and Compliance E‐Submission Form  (2048)

For General Correspondence submissions to CVB Inspection & 

Compliance (APHIS Form 2048), start by entering the CVB

secƟon of the Portal and then navigaƟng to the Create New

Submission to IC.

You will be taken to the CVB InspecƟon and Compliance E‐Submission Form. 

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PublicaƟon Date: 1/17/2020   Page 3

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Entering InformaƟon 

Serial Number ‐ Upon entering a Product Code, a new window will

pop up asking “Is there a Serial Number Ɵed to Product Code 

xxxxxx?” 

Do Not Enter Symbols (i.e. hyphens (‐) or slashes (/ \)). 

 If there is a Serial Number Ɵed to the Product Code, enter

it and then click

 ∗Repeat the process for each serial number associated

with the submission.

If the submission is not directly related to a serial number,

leave the field blank, and click

Establishment ‐ Self‐Explanatory.  

Product Code(s) ‐ Enter all applicable product codes directly related to the submission. Choose the to 

save the Code to the record and add mulƟple product codes. 

*Enter NA0000 for submissions that are not product related.

Fields with a red asterisk (*) are required. 

VBI # ‐ Only enter if an invesƟgaƟon number (VBI #) has been provided by the CVB‐InspecƟon and Compliance.

This must be in the format noted (##‐###).  

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PublicaƟon Date: 1/17/2020   Page 4

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Submission Type ‐ This is a mandatory field. Only one submission type may be chosen per submission. Choose

from one of the following available types:

• AER Correspondence ‐ Correspondence relaƟng to Adverse Events, whether requested from the CVB or

directly from the manufacturer regarding adverse events associated with a product or serial.

• AIR Correspondence ‐ Correspondence or responses associated with AdministraƟve InspecƟon Reviews

• General Correspondence (IC)* ‐ Any correspondence including leƩers referencing more than one product

code, or those that have no product associated. Also use this when submitting preliminary facility drawings

for CVB comment.

*NOTE: Use "General Correspondence (IC)" as default if other options do not apply.

• InspecƟon ‐ Correspondence relaƟng to an inspecƟon performed by CVB-IC. This may include acƟon item

responses or clarificaƟon requests.

• InvesƟgaƟon ‐ Correspondence relaƟng to an invesƟgaƟon iniƟated by the CVB‐IC. Be sure to include the

VBI number in the applicable field.

• Product Correspondence (IC) ‐ Any correspondence associated with ONE product code. If more than one

product code is associated with the correspondence, use General Correspondence (IC).

• Facility Documents - Refer to NCAH Portal User Guide #26, Submitting Facility Documents to Inspection and

Compliance (IC).

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PublicaƟon Date: 1/17/2020   Page 5

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

(Submission) Subtypes ‐ This is a Non‐Mandatory field. If applicable, mulƟple subtypes may be chosen. Select an entry 

from the list and click the button. Repeat for additional entries.

• Bench Records RelaƟng to a 2008 ‐ If Bench Records are requested by the CVB for a 2008 that is already

submiƩed to the CVB, create a new 2048 submission.

*Include the Product Code and Serial number for the selected record, if applicable.

• Immediate NoƟficaƟon ‐ The NCAH Portal may be uƟlized to submit immediate noƟficaƟons to the CVB in

accordance with 9 CFR 116.5(b) and VSM 800.57. Use this submission subtype for these types of noƟficaƟons.

If concise enough, the Brief DescripƟon may be uƟlized to provide the preliminary informaƟon without

addiƟonal aƩachments—remember this has a 200 character limit.

• Process DeviaƟon ‐ Include this subtype if a submission is related to a process deviaƟon ‐ any step of producƟon

that is outside of the standard requirement or outline of producƟon

*If the deviaƟon is related to specific serials, include the Product Code(s) and Serials Number(s).

*If the deviaƟon is related to a producƟon lot, include the AnƟgen name(s) and lot number(s) in the Brief

DescripƟon.

• Voluntary Stop Sale ‐ Include this subtype if a submission is noƟfying the CVB of a Voluntary Stop DistribuƟon

and Sale in accordance with VSM 800.57, Market Suspension, ensure to chose this subtype. This may be used in

conjuncƟon with the Immediate NoƟficaƟon subtype.

• Pharmacovigilance Onboarding - Apart of the on-boarding process for licensees/permittees to be in compliance 

with 9 CFR 116.9. To receive the guidance documents to use the Gateway for adverse event reporting (AERs), 

licensees/permittees should send this request to the CVB using this subtype. 

• Preliminary Facility Documents - This is intended to only be used with General Correspondence submission type.

Drawings submitted for comment prior to construction or anticipation of renovations. See VSM 800.78.

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Submission of APHIS Form 2007 

information should be submitted 

through the NCAH Portal Qualification 

of Veterinary Biologics Personnel 

(APHIS 2007) module.
PublicaƟon Date: 1/17/2020   Page 6

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Tags ‐ This is a Non‐Mandatory field, in which more than one tag may be chosen. Tags are primarily addiƟonal

informaƟon not specifically related to the submission informaƟon.

Product Distributed ‐ UƟlize this tag if any porƟon of the product/serial was distributed off licensed  

premises, for Voluntary Stop Sale and Immediate NoƟficaƟon submissions.

Firm Priority ‐ Use with discreƟon. Using this tag, will delay other submissions for the firm. Use this tag if

the submission is a high priority for the firm for processing.  

Brief DescripƟon ‐ This is a Mandatory field that should provide the purpose / subject of the submission. If

the submission is related to producƟon lots, include any lot numbers (if possible). Maximum character limit

is 200 (with spaces).

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PublicaƟon Date: 1/17/2020   Page 7

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Also NoƟfy (cc) ‐ This provides the firms the ability to “carbon copy” any individual(s) within the CVB. Select a

name from the list  and then click the          to add that person. Repeat to add addiƟonal  CVB Employees.

Related Submissions ‐ If applicable, the mail log number of any directly related submissions may be entered.

Include the mail log number if the submissions is a follow‐up to a CVB Response or if there are other items to

consider. MulƟple mail log numbers may be entered.

Select the (+) to select the mail log number.   

Repeat for each applicable mail log number.

Select the box when complete and then Save the record.

Direct Submission To ‐ This lists any Biologics Specialist within the CVB‐InspecƟon and Compliance Unit. This will

not route the submission directly to the recipient; it's used as a tool to help determine who the submission can be

manually routed to. Select one name from the list.

All 2048 submissions should have 

either an aƩached document or 

occasionally, a detailed explanaƟon in 

the Brief DescripƟon will be sufficient. 

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PublicaƟon Date: 1/17/2020   Page 8

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Allows the user to edit any field entered in the 2048 InformaƟon. NOTE: No submission that has been submiƩed

to the CVB can be edited (with the excepƟon of the aƩachment). See UpdaƟng a Portal Submission that is with

the CVB secƟon in this documents for guidance on updaƟng aƩachments.

Next ‐ Adding Attachments

This takes the user back to the CVB Dashboard.

The draŌ submission can be found in the “View DraŌ Submissions (APHIS 

Form 2048) to CVB” link in the CVB Dashboard. 

Allows the user to get a printer-friendly PDF document with the 2048 submission informaƟon, along 

with the submitted file information (no direct links), CVB Response file information (no direct links), and 

the submission history.

In cases of duplicate entries, or other mistakes, the user may delete an entire submission. No record 

of that submission will be able to be obtained upon deletion. 2048 InformaƟon.

NOTE: No submission that has been  submiƩed to the CVB can be deleted.

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PublicaƟon Date: 1/17/2020 Page 9

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Select to be able to add

aƩachment(s) to the record. MulƟple

aƩachments may be added for a single  

submission.

Select Browse to prompt a dialog box and add the File, Select 

Remove to delete the added File. 

File ‐ The CVB‐IC requests that the majority of the incoming documents be uploaded as a .pdf file.  

Type ‐ All files, including leƩers, bench records, or other requests for CVB‐IC will be entered as “Incoming   

Submission (Core)”.

Comments ‐ This is a Non‐Mandatory field limited to 150 characters. Comments pertaining specifically to the  

individual document may be entered here.

Next ‐ Submitting to the CVB

Click on the checkbox, then the Save to Submission button

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PublicaƟon Date: 1/17/2020 Page 10

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

#1 ‐ From the Submission: When the submission is complete and ready to send to the CVB,

click on                        (available to liaisons and alternate liaisons only).

#2 ‐ From the CVB Dashboard: Click on “View DraŌ Submissions (APHIS Form 2048) to CVB.”

Or choose the More info... link to review the individual submission and submit.

Next ‐ Updating a Portal Submission

Note the mail log (ML) ID that is returned to the portal user immediately.  

This idenƟfier is the most direct way of idenƟfying a parƟcular submission

when communicaƟng with the CVB.

There are 2 ways to Submit To CVB: 

1‐From the Submission 

2‐From the CVB Dashboard 

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PublicaƟon Date: 1/17/2020 Page 11

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

UpdaƟng a Portal Submission 

that is with the CVB 

In instances that a corrected leƩer, or addiƟonal informaƟon needs to be

added to a submission prior to CVB review of the original submission, the firm

may add or replace a document within that submission.  

However, the firm must first contact the CVB‐IC (either the Biologics Specialist

or the BCA) and request a “Request Info From SubmiƩer” acƟon. This request 

may be done by email or phone call to the CVB-IC representative. This will

move the submission into an Eligible Submission for the firm.

Any known search criteria may be entered, such as

Form type (APHIS 2048), Mail Log #, or Submission

Status (AwaiƟng Update from SubmiƩer will default

from the dashboard link).  

Upon entering the info, the Results will populate,

and you can choose the “Info” link to open the

record. If the Status is “AwaiƟng Update from

SubmiƩer”, you may append any aƩachment.

See Account Details User Guide for further guidance.

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PublicaƟon Date: 1/17/2020   Page 12

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Only Liaisons and Alternate Liaisons may append a 

document to a submission. The documents are 

transferred immediately to the CVB without a separate 

Submit to CVB acƟon. 

The Liaison or Alternate Liaison may append only

one document at a Ɵme.

Users may indicate that the new document        

supersedes/replaces a previously uploaded        

document, provided that the document type and file

extension (e.g., pdf) for both are the same.   

Once the appended document is submiƩed, an email

is sent to all CVB employees currently working with

the submission so they are aware of the update.

Comments ‐ Specify the nature of the document, whether it is a new file or supersedes another file,

and reason for the aƩachment.

Next ‐ Responses from the CVB

This will cause versioning in the CVB Mail Log, to 

ensure that CVB personnel are working with the 

most current version. Superseded versions are 

retained by the CVB for historical purposes. 

UpdaƟng a Portal Submission

that is with the CVB (conƟnued) 

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PublicaƟon Date: 1/17/2020  Page 13

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

Responses from the CVB 

2048 submissions transferred to the CVB are updated at defined Ɵmes in the course of CVB review/processing:

 When the CVB needs addiƟonal input from the submiƩer:  The status of the submission changes from SubmiƩed

to AwaiƟng Update from the SubmiƩer.

 When the CVB acknowledges receipt of the requested addiƟonal input:  The status of the submission changes back

to SubmiƩed aŌer being in AwaiƟng Update from the SubmiƩer status.

 Upon compleƟon of regulatory review:  The status of the submission changes to Completed.  The term

“completed” refers only to the status of regulatory review and has no bearing on whether the submiƩed

informaƟon was acceptable for the purpose intended. The CVB Response leƩer will detail this response, if

applicable.

• If a response is not needed by the CVB‐IC, a mail log

tag of “No Outgoing Correspondence” will be added.

This will display in the NCAH Portal as the CVB

Response.

If a response from the CVB is sent, the File (response letter) will be attached to the Submission Info page, along 

with the Attachment Type. 

CVB Response Types 

To see status update informaƟon of the 2048, including response leƩers from 

the CVB, and AƩachment Type informaƟon see your Submission History (CVB) 

page in the NCAH Portal.

Click here to see the Submission History (CVB) and Account Details User Guide.

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• “Voluntary Stop Distribution and Sale Acknowledged” - The CVB response for voluntary stop distribution and 

sale action based on a temperature excursion which is outside the Outline of Production or 9 CFR 114.11 

requirements and the firm decides to reject (Destroy) the product that was involved will be tagged as “No 

Outgoing Correspondence” and “Voluntary Stop Distribution and Sale Acknowledged”. 

• "Return Action Required by the Firm" - used in instances when the CVB Expects a response from 

the firm, usually in a given time frame.
PublicaƟon Date: 1/17/2020   Page 14

NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

CVB IniƟated Correspondence 

Occasionally the CVB will release to portal formal CVB correspondence that did not arise as a direct response to

something a portal user submiƩed. When this occurs, the Submission History will show the item was created by CVB.  

RetenƟon of 2048 items in the NCAH Portal 

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To see status informaƟon of 2048s see your Submission History (CVB) page in 

the NCAH Portal. 

Click here to see the Submission History (CVB) and Account Details User Guide.
NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

9

Submitters may generate a pdf report of the information on the completed 2048 entry screen at any time. 

Click on the “Save as PDF” button at the bottom of the detail page for any submission. 

Explanation of Statuses on the Account Details Page 

What are the different categories in "Status" on the Account Details page?

Submitted – Submission been sent from the NCAH portal to the CVB Mail Log and is an Active Mail log item. 

Awaiting Update from Submitter – Upon request by the firm to CVB (either by email or phone call to the 

Biologics Specialist or other IC Employee). See Updating a Portal Submission within the IC e-Submission User 

Guide for details on submission. 

Complete – The Mail activity has been completed for the Mail Log with one of the following outcomes: 

CVB Response, No Outgoing Correspondence, CVB Initiated Correspondence, Response is linked to a 

different Mail log Item. 

• CVB Response – The Outgoing Correspondence Files (Outgoing General Correspondence, Outgoing Compliance

Correspondence, Outgoing Enclosure document types) will be displayed within the CVB Response Files area.

continued on next page...

PublicaƟon Date: 1/17/2020 Page 15
NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

9

• No Outgoing Correspondence – The submission does not require an immediate response from the CVB-IC.

The incoming document has been received and filed.

Further explanation of "Complete" status...continued from previous page

• CVB Initiated Correspondence – Any correspondence that initiated at the CVB.

Note: the Submitter and Brief Description will be blank for these types of correspondence in this view. 

The Portal item info screen will indicate the submission is from CVB-IC, date submitted to the firm, and the response file(s). 

continued on next page... PublicaƟon Date: 1/17/2020 Page 16
NCAH	PORTAL	CVB	QUICK	REFERENCE	GUIDE	

General Guide for CVB InspecƟon & Compliance E‐Submission Correspondence 

(APHIS 2048) 

9

Response is linked to a different Mail log Item – CVB may link multiple mail logs together, where only one 

submission will contain the CVB Response (Functionally linked Mail log items). The mail log item, that does not have 

the outgoing correspondence, will have a CVB Response of “See ML xxxxxx for CVB Response to this Submission”. 

•

PublicaƟon Date: 1/17/2020 Page 17

Explanation of Statuses on the Account Details Page Further explanation of "Complete" status...continued from previous page